Ipsen's Rare Liver Disease Treatment Gets FDA OK

By Ben Glickman

Ipsen's treatment for the rare liver disease primary biliary cholangitis on Monday received approval from U.S. regulators.

The French pharmaceutical company said Iqirvo, which goes by the generic name elafibranor, had received accelerated approval from the U.S. Food and Drug Administration for the treatment of PBC, in combination with ursodeoxycholic acid.

The company said Iqirvo could be prescribed immediately in the U.S. for patients who have an inadequate response to ursodeoxycholic acid or as a monotherapy in patients who cannot tolerate ursodeoxycholic acid.

Ipsen has submitted Iqirvo for approval by European and U.K. regulators, with decisions expected in the second half of the year.

PBC is a rare autoimmune disease that involves a build-up of bile and toxins and chronic inflammation. It affects about 100,000 people in the U.S., Ipsen said.

Write to Ben Glickman at [e-mail]

(END) Dow Jones Newswires

06-10-24 1724ET